The Ministry of Science and Technology of China imposed penalties today (Oct 24th) on 6 companies for violating regulations on human genetic resources. AstraZeneca and 5 domestic companies are on the list. The punishment measures include suspending relevant research, confiscating and destroying relevant materials, and suspending companies’ applications for international cooperation and outbound activities involving China’s human genetic resources.
What Are Human Genetic Resources in China?
Before conducting clinical trials involving China’s genetic resources, overseas enterprises shall report to Human Genetic Resources Administration of China (HGRAC). China has published the Interim Measures for the Administration of Human Genetic Resources in 1998. Human genetic resources refer to the genetic materials such as human organs, tissues, cells, blood specimens, preparations of any types or recombinant DNA constructs, which contain human genome, genes and gene products.
What Are the Penalties?
Foreign enterprises shall report to the HGRAC after clinical trial approved by Ethics Committee, signed by hospitals and filed in local Medical Products Administration. If not reported, clinical trials will be suspended. If irregularities are committed, genetic resource data will not be available and clinical data will be rejected. Failure to report genetic resource data can also affect the ownership of clinical data.
For English version of Interim Measures for the Administration of Human Genetic Resources, please email info@ChinaMedDevice.com.
Siemens and Medtronic’s clinical data rejected as incompliances found in CFDA clinical audit. Click HERE for our comments.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.